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A Study of CNTY-101 in Participants With CD19-Positive B-Cell Malignancies (ELiPSE-1)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05336409
Recruitment Status : Recruiting
First Posted : April 20, 2022
Last Update Posted : April 23, 2024
Sponsor:
Information provided by (Responsible Party):
Century Therapeutics, Inc.

Tracking Information
First Submitted Date  ICMJE April 8, 2022
First Posted Date  ICMJE April 20, 2022
Last Update Posted Date April 23, 2024
Actual Study Start Date  ICMJE January 24, 2023
Estimated Primary Completion Date August 2025   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 19, 2022)
  • Maximum Tolerated Dose (MTD) as Determined by the Percentage of Participants With Dose Limiting Toxicities (DLTs) and DLTs Based on Severity [ Time Frame: Up to 28 days ]
  • Recommended Phase 2 Regimen (RP2R) as Recommended by the Safety Review Committee (SRC) [ Time Frame: Up to 28 days ]
Original Primary Outcome Measures  ICMJE
 (submitted: April 19, 2022)
  • Maximum Tolerated Dose (MTD) as Determined by the Percentage of Participants With Dose Limiting Toxicities (DLTs) and DLTs Based on Severity [ Time Frame: Up to 28 days ]
  • Recommended Phase 2 Regimen (RP2R) as Determined by the Safety Review Committee (SRC) [ Time Frame: Up to 28 days ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 19, 2022)
  • Complete Response Rate (CRR) Based on Percentage of Participants Achieving Complete Response (CR) [ Time Frame: Up to 2 years ]
    CRR will be determined using Recommendations for Initial Evaluation, Staging, and Response Assessment of Hodgkin and Non-Hodgkin Lymphoma: The Lugano Classification.
  • Objective Response Rate (ORR) Based on Percentage of Participants Achieving CR or Partial Response (PR) [ Time Frame: Up to 2 years ]
    ORR will be determined using Recommendations for Initial Evaluation, Staging, and Response Assessment of Hodgkin and Non-Hodgkin Lymphoma: The Lugano Classification.
  • Duration of Response (DOR) [ Time Frame: Up to 2 years ]
    DOR is defined as time from first response (CR or PR) to the first documentation of progressive disease (PD) or death.
  • Time to Treatment Response (TTR) [ Time Frame: Day 1 up to 2 years ]
    TTR is defined as time from first CNTY-101 infusion to the first documentation of response (CR or PR).
  • Progression-Free Survival (PFS) [ Time Frame: Day 1 up to 2 years ]
    PFS is defined as time from first CNTY-101 infusion to the first documentation of PD, or death from any cause, whichever occurs first
  • Overall Survival (OS) [ Time Frame: Day 1 up to 2 years ]
    OS is defined as time from CNTY-101 infusion to death.
  • Cmax: Maximum Observed Plasma Concentration for CNTY-101 [ Time Frame: Day 1 up to 2 years ]
  • Tmax: Time to Reach the Maximum Plasma Concentration for CNTY-101 [ Time Frame: Day 1 up to 2 years ]
  • t1/2: Terminal Disposition Phase Half-life for CNTY-101 [ Time Frame: Day 1 up to 2 years ]
  • AUC: Area under the Concentration-time Curve for CNTY-101 [ Time Frame: Day 1 up to 2 years ]
  • Percentage of Participants With at Least one Treatment Emergent Adverse Event (TEAE) [ Time Frame: Day 1 up to 2 years ]
  • Percentage of Participants With Clinically Significant Laboratory Abnormalities [ Time Frame: Day 1 up to 2 years ]
  • Time to Treatment Initiation [ Time Frame: Enrollment to first CNTY-101 infusion (up to approximately 2 weeks) ]
    Time to treatment initiation is defined as the time from enrollment in the study to first CNTY-101 infusion.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of CNTY-101 in Participants With CD19-Positive B-Cell Malignancies
Official Title  ICMJE The ELiPSE-1 Study: A Phase 1, Multicenter, Open-Label Study of CNTY-101 in Subjects With Relapsed or Refractory CD19-Positive B-Cell Malignancies
Brief Summary ELiPSE-1 is a Phase 1, multi-center, dose-finding study to evaluate the safety, pharmacokinetics, and preliminary efficacy of CNTY-101 in participants with relapsed or refractory cluster of differentiation (CD)19-positive B-cell malignancies.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • R/R CD19-Positive B-Cell Malignancies
  • Indolent Non-Hodgkin Lymphoma
  • Aggressive Non-Hodgkin Lymphoma
Intervention  ICMJE
  • Biological: CNTY-101
    CNTY-101 cells for intravenous (IV) infusion
  • Biological: IL-2
    IL-2 subcutaneous (SQ) injection
  • Drug: Lymphodepleting Chemotherapy
    LDC as prespecified in the protocol.
Study Arms  ICMJE
  • Experimental: Dose Escalation: Schedule A
    Lymphodepleting chemotherapy (LDC) will be followed by single dose administration of CNTY-101, alone or with supplemental human recombinant interleukin 2 (IL-2).
    Interventions:
    • Biological: CNTY-101
    • Biological: IL-2
    • Drug: Lymphodepleting Chemotherapy
  • Experimental: Dose Escalation: Schedule B
    LDC will be followed by administration of CNTY-101, 3 times over 3 weeks, alone or with supplemental IL-2.
    Interventions:
    • Biological: CNTY-101
    • Biological: IL-2
    • Drug: Lymphodepleting Chemotherapy
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: April 19, 2022)		 75
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE August 2027
Estimated Primary Completion Date August 2025   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Diagnosis of CD19-positive relapsed or refractory (R/R) B-cell Non-Hodgkin's Lymphoma (NHL).

  2. Must have met the following criteria for prior treatment:

    1. Participants with aggressive NHL must have received at least 2 lines of systemic therapy (if not intended for transplant, have already undergone or be unwilling or unable to undergo chimeric antigen receptor [CAR] T-cell therapy to be eligible), or at least 3 lines of systemic therapy. Previous therapy must have included a CD20-targeted agent and an anthracycline or alkylator.
    2. Participants with follicular lymphoma (FL) must have received at least 2 lines of systemic therapy and have high-risk disease. Previous therapy must have included a CD20-targeted agent and an alkylator.
    3. Participants with marginal zone lymphoma (MZL) must have received at least 2 prior systemic therapies.
  3. Measurable disease on screening evaluations.
  4. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
  5. Adequate organ function.
  6. Life expectancy of ≥12 weeks.

Exclusion Criteria:

  1. Any condition that confounds the ability to interpret data from the study.
  2. Central nervous system (CNS)-only involvement by malignancy. (Note: participants with secondary CNS involvement are allowed.)
  3. Prior allogeneic stem cell transplant.
  4. Presence of clinically significant CNS pathology.
  5. Other comorbid conditions defined in the protocol.
  6. Use of prohibited medications within the washout period defined in the protocol.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Nikolaus Trede 888-506-7670 ClinicalTeamCNTY@centurytx.com
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT05336409
Other Study ID Numbers  ICMJE CNTY-101-111-01 (ELiPSE-1)
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party Century Therapeutics, Inc.
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Century Therapeutics, Inc.
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Century Therapeutics, Inc.
Verification Date April 2024

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP